Description
Senior Regulatory Affairs AssociateLocation: Berkshire
Salary: £40,000 - £45,000 + excellent package
If you are looking for an opportunity which offers quick career progression, a friendly supportive environment and a stimulating work load this is the role for you.
Experience
- Extensive experience of clinical trial regulatory affairs either in CRO, pharmaceutical or biotechnology industry.
- May have transferable clinical research experience.
- May have experience in Devices or IVD Regulatory Affairs.
- Excellent understanding of the regulatory processes governing clinical trials of investigational medicinal products both within and outside of the EU.
Job Summary
- Compiles and submits clinical trial applications and notifications to regulatory authorities and ethics committees.
- Ensures clinical trials are conducted such that subjects' rights, safety and well being are protected and that the clinical trial data are reliable.
- Provides regulatory affairs advice and support for all projects.
- Assists with the management of regulatory affairs and technical writing services within
- Mentors regulatory affairs staff.
- Supports business development activities.
- Participates in all departmental project related activities.
- Prepares clinical trial applications in line with regulatory requirements.
- In conjunction with RA Management, creates and maintains specific project tracking systems incorporating all relevant information.
- Acts as a contact for and liaises with clients, project managers and other members of project teams to obtain relevant information to fulfil regulatory requirements.
Education/Qualifications Required
Graduate, postgraduate or equivalent, ideally in a scientific or healthcare discipline.
If you are interested in finding out more information please contact our Regulatory Team Manager Natalie Hopkins with your updated C.V at n.hopkins(a)realstaffing.com or call for more information.